None listed
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of pelvic drain versus no pelvic drain on lymphocele rate in men undergoing robot-assisted radical prostatectomy for prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or above and are undergoing robot-assisted radical prostatectomy for prostate cancer. Study details The study will compare the placement of pelvic drain versus no pelvic drain after robot-assisted radical prostatectomy (RARP). Patients will be allocated to one of two treatments based on chance alone. The intervention (drain or no drain) will be implemented at the end of the RARP operation. The urological surgeon will be responsible for the safe placement of drain (or no drain). The drain is made of plastic and is placed in the pelvis adjacent to the surgical bed. Duration of placement typically ranges from 12 to 36 hours. It is hoped that this study will provide high quality evidence to inform management for Australian and international urologists.
Interventions
The study will compare the placement of pelvic drain versus no pelvic drain after robot-assisted radical prostatectomy (RARP). There is a lack of high level evidence for or against pelvic drain in this setting and hence both of these practices are currently routinely used and are considered standard of care.
All patients undergoing RARP for prostate cancer will be offered recruitment into this trial. Written and verbal information will be provided to patients prior to obtaining informed consent
The study will compare the placement of pelvic drain versus no pelvic drain after robot-assisted radical prostatectomy (RARP). There is a lack of high level evidence for or against pelvic drain in this setting and hence both of these practices are currently routinely used and are considered standard of care. All patients undergoing RARP for prostate cancer will be offered recruitment into this trial. Written and verbal information will be provided to patients prior to obtaining informed consent. The intervention (drain or no drain) will be implemented at the end of the RARP operation. The urological surgeon will be responsible for the safe placement of drain (or no drain). The drain is made of plastic and is placed in the pelvis adjacent to the surgical bed and urethrovesical anastomosis. A bellows (200ml capacity) and bag (700ml capacity) are attached to the drain extra-corporeally to form a closed circuit. Duration of placement typically ranges from 12 to 36 hours.
Sponsors
Nepean Urology Research Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any patient undergoing robot-assisted radical prostatectomy for prostate cancer
Exclusion criteria
Prior pelvic radiotherapy Prior pelvic surgery Distant metastatic prostate cancer
Outcome results
None listed